Response Adapted Neoadjuvant Therapy in Gastroesophageal Cancers (RANT-GC Trial) - a Phase Ib Feasibility Trial
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Percentage of completing per protocol treatment.
研究概览
简要总结
This is a phase 1b prospective, single arm, open-label trial determining the efficacy and feasibility of using a response-guided approach to help guide neoadjuvant chemotherapy in subjects with Stage IB, II or Stage III adenocarcinoma of the stomach or gastroesophageal junction (GEA).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have histologically or cytologically confirmed adenocarcinoma of the stomach or gastroesophageal junction (GEA). Other GE histologies which are treated per NCCN guidelines for neoadjuvant treatment are eligible.
- •Must have Stage IB, II or Stage III GEA eligible for (neo)adjuvant doublet or triplet chemotherapy for up to 6 months.
- •Age ≥ 18 years Because the safety or efficacy of neoadjuvant chemotherapy for LGEA has not been tested or established for patients <18 years of age, children are excluded from this study but will be eligible for future pediatric trials, if applicable.
- •Performance status: ECOG performance status ≤2
- •Life expectancy of greater than 6 months
- •Adequate organ and marrow function as defined below:
- •hemoglobin ≥ 7g/dL
- •absolute neutrophil count ≥ 1,500/mcL
- •platelets ≥ 80,000/mcl
- •total bilirubin within normal institutional limits
- •AST(SGOT)/ALT(SPGT) ≤ 5 X institutional upper limit of normal
- •creatinine <2 X ULN
- •Docetaxel can cause fetal harm and irinotecan is known to be teratogenic. Since these compounds are part of the treatment regimens, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- •1. A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
- •Has not undergone a hysterectomy or bilateral oophorectomy; or
- •Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
- •Ability to understand and the willingness to sign a written informed consent.
- •Both men and women and members of all races and ethnic groups are eligible for this trial. Non-English speaking, deaf, hard of hearing and illiterate individuals are eligible for this trial.
排除标准
- •Patients may not be receiving any other investigational agents.
- •Patients with known distant metastases from GEA.
- •History of allergic reactions attributed to agents used in study.
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- •History of another primary cancer which requires active treatment or is expected to require treatment within 12 months after enrollment.
- •Inability to comply with study and follow-up procedures as judged by the Investigator.
- •Patients who are pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
- •Patients with prior organ/bone marrow/non-autologous stem cell transplants
研究组 & 干预措施
Neoadjuvant chemotherapy with ctDNA testing
The patients will be treated with one of the standard neoadjuvant protocols (FLOT or FOLFOX.) If patient response to their treatment, as measured by CT Scans or MRI results or blood tests done to look tumor markers such as carcinoembryonic antigen (CEA) and Carbohydrate antigen 19-9 (CA19-9) a change in adjuvant treatment will be made.
干预措施: FLOT (Combination Product)
Neoadjuvant chemotherapy with ctDNA testing
The patients will be treated with one of the standard neoadjuvant protocols (FLOT or FOLFOX.) If patient response to their treatment, as measured by CT Scans or MRI results or blood tests done to look tumor markers such as carcinoembryonic antigen (CEA) and Carbohydrate antigen 19-9 (CA19-9) a change in adjuvant treatment will be made.
干预措施: FOLFOX (Combination Product)
Neoadjuvant chemotherapy with ctDNA testing
The patients will be treated with one of the standard neoadjuvant protocols (FLOT or FOLFOX.) If patient response to their treatment, as measured by CT Scans or MRI results or blood tests done to look tumor markers such as carcinoembryonic antigen (CEA) and Carbohydrate antigen 19-9 (CA19-9) a change in adjuvant treatment will be made.
干预措施: FOLFIRI (Combination Product)
Neoadjuvant chemotherapy with ctDNA testing
The patients will be treated with one of the standard neoadjuvant protocols (FLOT or FOLFOX.) If patient response to their treatment, as measured by CT Scans or MRI results or blood tests done to look tumor markers such as carcinoembryonic antigen (CEA) and Carbohydrate antigen 19-9 (CA19-9) a change in adjuvant treatment will be made.
干预措施: FOLFIRINOX (Combination Product)
Neoadjuvant chemotherapy with ctDNA testing
The patients will be treated with one of the standard neoadjuvant protocols (FLOT or FOLFOX.) If patient response to their treatment, as measured by CT Scans or MRI results or blood tests done to look tumor markers such as carcinoembryonic antigen (CEA) and Carbohydrate antigen 19-9 (CA19-9) a change in adjuvant treatment will be made.
干预措施: PACLITAXEL with or without CARBOPLATIN (Combination Product)
Neoadjuvant chemotherapy with ctDNA testing
The patients will be treated with one of the standard neoadjuvant protocols (FLOT or FOLFOX.) If patient response to their treatment, as measured by CT Scans or MRI results or blood tests done to look tumor markers such as carcinoembryonic antigen (CEA) and Carbohydrate antigen 19-9 (CA19-9) a change in adjuvant treatment will be made.
干预措施: DOCETAXEL and IRINOTECAN (alone or combined) (Combination Product)
Neoadjuvant chemotherapy with ctDNA testing
The patients will be treated with one of the standard neoadjuvant protocols (FLOT or FOLFOX.) If patient response to their treatment, as measured by CT Scans or MRI results or blood tests done to look tumor markers such as carcinoembryonic antigen (CEA) and Carbohydrate antigen 19-9 (CA19-9) a change in adjuvant treatment will be made.
干预措施: NIVOLUMAB (alone or when added to a regimen above) (Drug)
Neoadjuvant chemotherapy with ctDNA testing
The patients will be treated with one of the standard neoadjuvant protocols (FLOT or FOLFOX.) If patient response to their treatment, as measured by CT Scans or MRI results or blood tests done to look tumor markers such as carcinoembryonic antigen (CEA) and Carbohydrate antigen 19-9 (CA19-9) a change in adjuvant treatment will be made.
干预措施: PEMBROLIZUMAB (alone or when added to a regimen above) (Drug)
Neoadjuvant chemotherapy with ctDNA testing
The patients will be treated with one of the standard neoadjuvant protocols (FLOT or FOLFOX.) If patient response to their treatment, as measured by CT Scans or MRI results or blood tests done to look tumor markers such as carcinoembryonic antigen (CEA) and Carbohydrate antigen 19-9 (CA19-9) a change in adjuvant treatment will be made.
干预措施: Durvalumab (Drug)
Neoadjuvant chemotherapy with ctDNA testing
The patients will be treated with one of the standard neoadjuvant protocols (FLOT or FOLFOX.) If patient response to their treatment, as measured by CT Scans or MRI results or blood tests done to look tumor markers such as carcinoembryonic antigen (CEA) and Carbohydrate antigen 19-9 (CA19-9) a change in adjuvant treatment will be made.
干预措施: Trastuzumab (Drug)
结局指标
主要结局
Percentage of completing per protocol treatment.
时间窗: Up to 3 years
Percent of patients who will undergo attempt at curative intent resection.
次要结局
- Percentage of patients completing gastrectomy.(Up to 3 years)
- Rate of negative ctDNA after completion of neoadjuvant treatment and within 8 weeks after surgery(8 weeks)
- Rate of R0 resection(Up to 3 years)
- Percentage of Grade 3-5 Adverse Events(Up to 3 years)
- Relapse-free survival time(Up to 3 years)
研究者
Farshid Dayyani
Professor of Clinical Medicine
University of California, Irvine